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Nurse-led Case Management for Diabetes and Cardiovascular Disease Patients With Depression

1 maggio 2014 aggiornato da: Wayne Katon, University of Washington

Randomized Trial of Liaison Psychiatry in Primary Care

This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Depression is a serious medical illness that has been associated with increased risk for heart disease and diabetes. Depression may negatively impact aspects of self-care that are required to effectively manage such long-term diseases. In depressed people who have heart disease and/or diabetes, treatment for depression appears to result in only limited improvements in depression symptoms and no improvements in heart disease and diabetes symptoms. An integrated treatment approach may be more effective in improving all three conditions. This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.

Participants in this single-blind study will be randomly assigned to take part in the case management intervention or receive usual care. All participants will attend 5 in-person study evaluation visits and receive 4 follow-up phone calls over 24 months. At each of the study visits, measurements of height, weight, waist size, and blood pressure will be taken. At study evaluations, blood and urine samples will also be taken. Participants will be asked not to eat for 8 hours before providing blood samples at 3 of the visits. During follow-up phone calls participants will answer various questions.

The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress. Outcomes will be measured at Months 6, 12, 18, and 24 months.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

214

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Washington
      • Seattle, Washington, Stati Uniti, 98101
        • Group Health Cooperative

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Diagnosis of diabetes and/or heart disease
  • Poor disease control (defined as an HbA1c level of at least 8.5%, blood pressure greater than 140/90 mm Hg, LDL cholesterol greater than 130 mg/dL)
  • Diagnosis of major depressive disorder

Exclusion Criteria:

  • History of psychosis
  • At high risk for suicide
  • Cognitive impairment
  • Current alcohol or substance abuse disorder
  • Does not own a telephone
  • Currently seeking psychiatric care
  • Pregnant or breastfeeding
  • Currently enrolled in a Group Health Cooperative disease management program
  • Terminal illness
  • Plans to leave Group Health Cooperative in less than a year
  • Does not speak English

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: B
Treatment as usual
Comportamentale: Treatment as usual
Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care.
Sperimentale: A
Case management intervention
Comportamentale: Nurse-led case management
The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c
Lasso di tempo: Baseline to 12 months
A scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL: all data submitted as Outcome Measures #2-5 below) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.The model was estimated by iterating between estimation of the covariance associated with the outcomes and generalized-estimating equation estimation of scaled outcomes. Effect size is estimated as Cohen d effect size that was use for the depression outcome is the difference in change from baseline to 12 months in the intervention and usual care groups divided by the pooled base line standard deviation. Thus, a d of 0.25 indicates that one-quarter of a standard deviation separates the two means. Cohen has suggested that an effect size of 0.20 would be considered small, 0.50 medium and 0.80 large.
Baseline to 12 months
Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months
Lasso di tempo: Measured at Baseline, 6 Months, 12 months

SCL-20 is a 20 question checklist in which items are averaged to yield a potential score of 0 to 4 with higher scores indicating more severe depression symptoms.

For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
Measured at Baseline, 6 Months, 12 months
Systolic Blood Pressure at Baseline, 6 Months and 12 Months
Lasso di tempo: Measured at Baseline, 6 Months, 12 months

Systolic Blood Pressure was measured at Baseline, 6 months and 12 months

For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
Measured at Baseline, 6 Months, 12 months
LDL Cholesterol at Baseline and 12 Months
Lasso di tempo: Measured at Baseline and 12 months

LDL Cholesterol was measured at Baseline and 12 months

For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
Measured at Baseline and 12 months
Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months
Lasso di tempo: Measured at Baseline, 6 months and 12 months

Glycated hemoglobin (HbA1c) was measured at Baseline, 6 months and 12 months

For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.
Measured at Baseline, 6 months and 12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Functional Impairment
Lasso di tempo: Measured at Months 6, 12 months
Disability was measured by the Sheehan Disability scale which measures the extent to which health interferes with social, vocational and familial functioning each on a 0 to 10 Likert scale where 0 is "not at all" and 10 is "extremely". This scale consists of 3 items which are averaged together to create the average disability score, which ranges from 0 to 10.
Measured at Months 6, 12 months
Health Care Costs
Lasso di tempo: Cumulative outpatient costs over 24 months
Mean total outpatient costs for 2 years post baseline adjusted for age, gender and previous 12 months of outpatient costs
Cumulative outpatient costs over 24 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Washington

Collaboratori

National Institute of Mental Health (NIMH)

Investigatori

  • Investigatore principale: Wayne J. Katon, MD, University of Washington

Pubblicazioni e link utili

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Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2007

Completamento primario (Effettivo)

1 ottobre 2010

Completamento dello studio (Effettivo)

1 agosto 2012

Date di iscrizione allo studio

Primo inviato

1 maggio 2007

Primo inviato che soddisfa i criteri di controllo qualità

1 maggio 2007

Primo Inserito (Stima)

3 maggio 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

2 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 maggio 2014

Ultimo verificato

1 maggio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • R01MH041739 (Sovvenzione/contratto NIH degli Stati Uniti)
  • DSIR 82-SEPC

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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